General Dynamics Information Technology – Federal Civilian Division is looking for a Medical Writer to join our team to support the Department of Army. This position is based in the Ft. Detrick and Frederick, Maryland areas.
In this role, the Medical Writer will:
Write, review, edit, and advise on the development of documents and dossiers in an electronic Common Technical Document (eCTD) format, to include IND applications, master files, investigational new device applications, biologics license applications, new drug applications, annual reports, information amendments, clinical protocols and study reports, investigator’s/investigational brochures, FDA meeting requests and background materials, responses to FDA requests for information, target product profiles, clinical development plans, manuscripts, white papers, 510k pre-market notifications, and to a lesser extent pre market approvals, and Environmental Protection Agency registration packages.
Use eCTD format to produce compliant writing products.
Maintain a writing product tracker to ensure regulatory deadlines are met for annual reports, FDA requests for information, and overall product submission timelines
Attend meetings to document all regulatory tasks and activities associated with the product development life cycle.
Provide routine reports and updates to the Government leadership.
Respond to questions and provide advice on activities and issues related to documentation.
Participate in special projects as required.
Bachelor’s Degree in Science field or a related discipline, or the equivalent combination of education, professional training, or work experience.
5 years of related medical or regulatory writing experience.
Have excellent Microsoft Office skills and experience with eCTD formatting.
Excellent written and oral communication skills.
Must be U.S. citizen and be able to obtain a TI (Public Trust).
We are GDIT. The people supporting some of the most complex government, defense, and intelligence projects across the country. We deliver. Bringing the expertise needed to understand and advance critical missions. We transform. Shifting the ways clients invest in, integrate, and innovate technology solutions. We ensure today is safe and tomorrow is smarter. We are there. On the ground, beside our clients, in the lab, and everywhere in between. Offering the technology transformations, strategy, and mission services needed to get the job done.
GDIT is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other protected class.